(92 days)
This device is intended for cemented use only as part of a layered construct and is indicated for patients with conditions of, but not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli. cystic acetabular roof. reconstruction in cases of defects after fracture. acetabular loosening, tumors or revision surgery, advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis, and failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis. hemi-arthroplasty. or total hip replacement.
The Zimmer Trabecular Metal Acetabular Revision System Cage is a device intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiencies, such as pelvic defects and discontinuities. The cage is a metallic, dome-shaped, flanged acetabular component with multiple screw holes for adjunct intraoperative peripheral stabilization of revision shell constructs. The cage is available in five sizes configured in both right and left versions along with either short or long flanges to meet various anatomical needs. It offers intraoperative flexibility of implant orientation/positioning to accommodate patient anatomies. The cage is fabricated from Commercially Pure (CP) Titanium
Here's an analysis of the provided text regarding the Zimmer Trabecular Metal™ Acetabular Revision System Cage, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device is a medical implant (Acetabular Cage), and the review focuses on substantial equivalence to a predicate device rather than performance against predetermined acceptance criteria typically seen in clinical trials for diagnostic devices or new technologies.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary of Evidence) |
|---|---|
| Substantial Equivalence to Predicate Device | * Intended Use: Both the proposed device and the predicate (Burch/Schneider™ Reinforcement Cage, K960678) are intended for revision hip surgeries to bridge areas of acetabular bone loss in patients with acetabular bone deficiency. |
- Non-Clinical Performance: Engineering evaluations were performed to verify that the performance of the device would be adequate for anticipated in vivo use. |
| Safety and Effectiveness | * The FDA reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination implies that the FDA believes the device is as safe and effective as its predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with a test set in the manner of a diagnostic device or a new therapeutic intervention. Instead, it refers to design verification through non-clinical engineering evaluations.
- Sample Size for Test Set: Not applicable in the context of a clinical test set. The document refers to "engineering evaluations," which would involve testing of prototypes or materials according to established standards. The sample sizes for these engineering tests are not specified.
- Data Provenance: Not applicable for a clinical test set. The "engineering evaluations" would have been conducted by the manufacturer, Zimmer, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable or provided because the review is based on substantial equivalence to a predicate device and non-clinical engineering evaluations, not a clinical study requiring ground truth established by expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable or provided as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done based on the provided text. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This question is not applicable as the device is a physical medical implant (Acetabular Cage), not an algorithm or software. Therefore, the concept of "standalone performance" in this context is irrelevant.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in clinical or diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. The device's safety and effectiveness were established through:
- Substantial equivalence to a legally marketed predicate device.
- Non-clinical engineering evaluations to verify performance against anticipated in vivo use. The "ground truth" for these engineering evaluations would be established engineering standards, material properties, and biomechanical principles.
8. The Sample Size for the Training Set
This information is not applicable or provided. The document details a 510(k) premarket notification for a physical medical device, not an AI or machine learning algorithm that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided for the same reasons as #8.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.